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Heart study tests if lowering 'Bad' cholesterol even more saves lives

NCT ID NCT04626973

Disease control Sponsor: Yonsei University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 3048 adults with heart or blood vessel disease to see if lowering LDL ('bad') cholesterol to a very low level (below 55 mg/dL) is better than the standard target (below 70 mg/dL). Participants received either a statin alone or a statin plus ezetimibe. The goal was to reduce the risk of heart attacks, strokes, and other major events. The trial is complete and results will help guide cholesterol treatment in Asian populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

3,048 people

The number who actually took part.

Started

Jan 2021

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 19-80 years 2. Documented atherosclerotic cardiovascular disease (ASCVD) * Previous acute coronary syndrome (myocardial infarction \[MI\] or unstable angina), * Or stable angina with imaging or functional studies * Or coronary revascularization (percutaneous coronary intervention \[PCI\], coronary artery bypass graft \[CABG\], and other arterial revascularization procedures) * Or stroke and transient ischemic attack (TIA) * Or peripheral artery disease Exclusion Criteria: 1. LDL-cholesterol level less than 70 mg/dL without statin therapyAllergy or hypersensitive to ezetimibe or statin 2. Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range 3. Allergy or hypersensitivity to any statin or ezetimibe 4. Solid organ transplantation recipient 5. Pregnant women, women with potential childbearing, or lactating women 6. Life expectancy less than 3 years 7. Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator 8. Inability to understand or read the informed content

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease coronary artery disorder Dyslipidemias

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerotic cardiovascular disease

Contacts and locations

Locations

  • Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

    Seoul, South Korea

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Other studies related to the condition(s) this trial covers.